Recro Pharma, Inc.

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 29, 2020 Recro Pharma, Inc. (Exact name of registrant as specified in its charter) Pennsylvania 001-36329 26-1523233 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) 490 Lapp Road, Malvern, Pennsylvania 19355 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (484) 395-2470 Not Applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol Name of Exchange on Which Registered Common Stock, par value $0.01 REPH Nasdaq Capital Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Transcript of Recro Pharma, Inc.

Page 1: Recro Pharma, Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSIONWashington, DC 20549

FORM 8-K

CURRENT REPORTPursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 29, 2020

Recro Pharma, Inc.(Exact name of registrant as specified in its charter)

Pennsylvania 001-36329 26-1523233

(State or other jurisdiction ofincorporation or organization)

(CommissionFile Number)

(I.R.S. EmployerIdentification No.)

490 Lapp Road, Malvern, Pennsylvania 19355(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (484) 395-2470

Not Applicable(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of thefollowing provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class TradingSymbol

Name of Exchangeon Which Registered

Common Stock, par value $0.01 REPH Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of thischapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any newor revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 8.01 Other Events.

On July 29, 2020, Recro Pharma, Inc. (the “Company”) updated information reflected in a slide presentation, which is attached as Exhibit 99.1 to thisCurrent Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation in variousmeetings with investors from time to time.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are being filed herewith: Exhibit No. Document

99.1 Investor Presentation of Recro Pharma, Inc.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by theundersigned, thereunto duly authorized.

Recro Pharma, Inc.

By: /s/ Gerri A. HenwoodName: Gerri A. HenwoodTitle: Chief Executive Officer

Date: July 29, 2020

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Exhibit 99.1

…focused on improving patients lives… July 2020

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Forward Looking Statements This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to the Company’s ability to manage costs and to achieve its financial goals; to operate under increased leverage and associated lending covenants; to pay its debt under its credit agreement and to maintain relationships with CDMO commercial partners and develop additional commercial partnerships. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this presentation. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the Company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or disruption in raw materials or supply chain; demand for the Company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the Company’s manufacturing services; the average profitability, or mix, of the products the Company manufactures; the Company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the Company manufactures, including active pharmaceutical

ingredients, excipients, purchased components and raw materials, or the Company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

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Company Highlights • Revenue and cash flow positive contract development and manufacturing (CDMO) business 2020 – Q1 Financial Results: • Revenue: $21.8 million • Operating Loss, from continuing operations: $(2.6) million • Cash and cash equivalents: $19.9 million – Expanded business development team early Q1 2020 – Announced new CTM and logistics business offerings in May 2020

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Gainesville CDMO Facilities Gould Campus Chestnut Facility Leased through 2025, with extension optionality 24,000 ft2 total, with 11,000 ft2 currently unused in facility, all readily able to be converted for clinical use Available adjacent empty lot of similar size to current site Same owner for both properties, giving Recro inside track to secure lot if needed Recro has right of first refusal for proposed development of the adjacent lot as well as the right to reject any proposed development 4

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Two Nearby Facilities Seamlessly Connected Recro’s neighboring sites work in concert to provide unified performance Facility Locations Commentary § Recro CDMO has two facilities located in Gainesville, Georgia§ Recro’s Gould facility, which focuses on commercial and controlled substance production, is located just four miles from the Chestnut facility, which specializes in development and formulation, clinical trial materials and logistics projects, and high potency production§ The close proximity allows the facilities to work hand-in-hand, as employees and resources can seamlessly move from one to the other, increasing knowledge sharing and creating significant teamwork synergies§ The facilities are ideally located within ~60 miles of Hartsfield-Jackson International Airport, and in close proximity to Interstates 75 and 85, significant commerce arteries in the eastern U.S. § All equipment available at Gould is available on a smaller scale at Chestnut§ Seamless integration between sites due to same support staff for facilities, quality, and project management Gould Facility Chestnut Facility 5 435

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CDMO Overview 97,000 + sq. ft. cGMP solid oral dosage manufacturing –DEA licensed Plus 24,000 sq. ft. –Development Services Facility and High Potency Product Facility CDMO Manufacturing Revenues include commercial product sales and profit sharing, along with development services revenues Continued revenue from commercial products, solid starts and repeat customers in development Ritalin LA® Oncedaily ADHD treatment marketed by Novartis* Focalin XR® Extended release ADHD treatment marketed by Novartis* Verapamil/Verelan CV/high blood pressure treatment marketed by Teva** and Lannett ZohydroER® Extended release hydrocodone marketed by Currax(Previously Pernix) * Five-year contract extension to December 2023 6 ** Six-year contract extension through 2024

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Start With, Stay With Recro Recro’s capabilities across the product development value chain Formulation CTM Regulatory Product Commercial Pre-IND Optimization Scale-Up PPQ Filing Launch Supply Development Manufacture Project Management Development Expertise Manufacturing Expertise Quality Assurance Regulatory Guidance and Consultation FORMULATION ANALYTICAL METHOD PHARMACEUTICAL PHARMACEUTICAL DEVELOPMENT DEVELOPMENT MANUFACTURING PACKAGING & LOGISTICS Capsules, tablets Raw material Milling Bottles (development scale) In-process Blending Serialization in place Physical Release Compression characterization Method development/ Spray granulation Early Phase Excipient compatibility validation Rotary granulation Late Phase & Solubility assessment ICH, photostability Particle/bead coating Commercial Encapsulation 7

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Business Model Approach Chestnut Phase I-IIb High Potency Early Phase Non-GMP CTM & Commercial Facility Development Feasibility Logistics Manufacturing Robust Technology Transfer Process Process Gould DEA Drug Phase III Scale Up & Commercial Development Facility CTM Development Manufacturing Phase I-IIb Support Early Phase Late Phase & Commercial 8

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Recro’s Registrantion & Commercial Approach Scale-Up PPQ Regulatory Filing Product Launch Registration & PPQ Late Phase Regulatory Technology Transfer Commercialization Strategy Support Scalable equipment Registration Batches eCTD compliance Commercial supports technology PPQ Campaign Regulatory guidance Manufacturing & transfer and consultation for Packaging Project Management client FDA meetings Pharmacovigilance continuity and responses reporting Categories 1 – 3A/3B and DEA Controlled Substance Capabilities Project Management 9

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Scalable Equipment Streamlines Technology Transfer Roller Fluid Bed Rotor Granulation Blending Processing Processing Compaction Key Unit Operations for Solid Oral Dosage Forms Milling Compression Tablet Coating Oven Drying (Temp & Encapsulation (Bi-Layer Capable) (Solvent Capable) Humidity Control) 10

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CDMO –High Potency and Development Services Services for both Development-phase small molecules and, within dedicated sector, for high potency molecules: Formulation Development Analytical Method Pharmaceutical Development Capsules, tablets Development Manufacturing Pharmaceutical Packaging (development scale) Raw material Milling & Logistics Physical In-process Blending Clinical trial supplies characterization Release Compression o Over encapsulation Excipient compatibility Method Spray granulation of controls Solubility assessment development/validation Rotary granulation o Randomization Regulatory guidance ICH, photostability Particle/bead coating o Clinical trial packaging Encapsulation o Stability testing Pre-clinical through Shipping o and logistics Phase III Serialization in place at Transfer non-high Gould facility for potency to commercial commercial packaging operations at Gould location 11

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Company Highlights Revenue and cash flow positive contract development and manufacturing (CDMO) business 2020 – Q1 Financial Results: Revenue: $21.8 million Operating Loss, from continuing operations: $(2.6) million EBITDA, as Adjusted (Standalone)*: $2.7 million Cash and cash equivalents: $19.9 million – Expanded business development team early Q1 2020 – Announced new CTM and logistics business offerings in May 2020 *EBITDA, as Adjusted (Standalone) is a non-GAAP financial measures (See reconciliation on last page of presentation). 12

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…focused on improving patients lives… July 2020